Oversees and implements research projects of high complexity in a variety of health-related or programmatic areas of research. Leads the project team and oversees daily operational activities of the project, including hiring and supervising study staff and managing participant recruitment/enrollment and data collection. Ensures compliance with grant/contract and regulatory requirements. Collaborates on study design and protocol development. Develops study materials and Institutional Review Board (IRB) applications. May participate in study analyses, quality assurance, and data interpretation. May participate in the dissemination of research findings. Communicates with Principal Investigator (PI) regarding progress of research. Manages or oversees administrative resources by conducting long-range project planning and developing and managing project budgets. Meets quality standards and deliverables during all phases of the research project life cycle from research application development to project closeout. Works with research operations leadership to mentor and train staff, build and maintain scientific quality, and implement strategies to continuously improve study management protocols and procedures. Understands and manages crucial interactions between enterprise-wide business and clinical environments, project implementation, and achievement of scientific aims.

Project Planning, Implementation & Quality Assurance:  Create/oversee creation and maintenance of timelines, ensuring adherence to milestones, prioritizing study tasks, and reviewing progress.  Plan/facilitate meetings (internally & multi-site) and develop content (agendas/minutes).  Develop/oversee development of study materials, recruitment procedures, data collection instruments and tracking systems.  Oversee recruitment & data collection.  Develop/implement data quality procedures.  Liaise across organizational departments, facilitating coordinated strategies to effectively implement research protocols.  Create/maintain operational documentation.  Problem-solve on recruitment/retention, quality assurance, and resource allocation issues.  Continuously identify/implement process improvements to enhance team functioning.  Champion key technical/operational needs to management.  Develop/maintain virtual sites or collaboration tools for multi-site content and data sharing.

Communication, Supervision & Leadership: Hire, train, and supervise project staff.  Facilitate effective communication among study personnel, collaborators, and consultants.  May serve as primary point of contact for subcontractors and funding agency officers. Manage contracts with outside vendors and independent contractors.  Develop/maintain project communication platforms such as newsletters or websites.  Play leadership role within the unit and KPWHRI by participating in workgroups & improvement initiatives and taking on ad hoc work.  May play leadership role in multi-site networks.  Train/mentor other Project Managers (PMs), faculty, unit managers, and staff.  May act as matrix or direct supervisor for other PMs.  Identify/promote best practices across the unit and KPWHRI.  When working in a programmatic area of research, may determine priorities and allocation of shared resources, participate in strategic planning, and monitor ongoing & anticipated project needs.

Budget Management: Oversee the development and management of budgets for highly complex research projects (including multifaceted or multi-site studies).  Identify/forecast personnel and other resource requirements (including long-range forecasting across multiple budget years).  Participate in priority setting and resource allocation decisions, and take actions to meet resource needs.  Coordinate and/or approve labor distribution for staff charging effort to projects.  Assure timely submission of budget related items for grant and contract applications.  Approve and reconcile project-related budget expenditures.  Forecast expenditures, monitor spending, and identify discrepancies using available financial tools.  Anticipate budget variances and independently implement corrective measures when indicated.

Funding & Regulatory Compliance: Prepare IRB applications, modifications, and annual continuation reports.  Ensure compliance with IRB and HIPAA regulations.  Ensure adherence to federal or other agency requirements.  Prepare and maintain Data Use Agreements and other data compliance documentation.  May monitor subcontracts to ensure compliance, under direction of PI.  Manage multi-site IRB approval where KPWHRI is the IRB of record for multiple sites.  In collaboration with PI, prepare and submit study progress reports as needed.  Maintain comprehensive knowledge of federal and other agency grant & contract management policies to be able to serve as a resource to other PMs.

Science & Analysis/Research Partnership:  Assist in development, preparation and timely submission of new research proposals.  Independently prepare sections of new research proposals.  As project needs dictate, conduct analysis and interpretation of data.  Participate in research study design.

Independently write technical reports.  Provide consultation in particular areas of expertise to project team members.  Contribute to study manuscripts as a lead or co-author.  Disseminate research findings through presentations and/or posters.  Extensive interaction with programmers, which may include: collaborating on the development of plans for study design and analysis; providing guidance or setting priorities for ongoing programming activities; participating in the review of analytic tables/results.